Tuesday, February 18, 2014

GUEST POST - The Lundbeck Runaround

The following is a guest post from Cheryl Buchanan. Cheryl has previously written a guest post on this blog [link at bottom] - this is an update regarding her mission to seek the truth from Lundbeck, a Danish pharmaceutical company who manufacture the antidepressant citalopram, known by its brand name of Cipramil and known in the US as Celexa.

Back in December Bob Fiddaman very kindly invited me to write a guest post for his blob. I had contacted him after finding his blog while scouring the Internet for information about anti depressants and birth defects. I had just discovered that before, and during, the time of my first pregnancy in 2004 I had been prescribed the SSRI antidepressant citalopram. My daughter was born at 23 weeks gestation, she had multiple abnormalities and was incompatible with life.

Upon speaking to Bob I sadly discovered I was not alone and that there have been many women whose children developed birth defects in pregnancy while their mothers were taking citalopram and other SSRIs.

At the time I was assured it was safe and was wholeheartedly encouraged to keep taking it. I was on a very high dose (60mg) which is no longer prescribed as its known to cause long QT syndrome in adults.

It has now also been proven that it can cause birth defects, especially those related to the heart and abdominal wall. My daughter had no diaphragm and other abnormalities, all of the details are included in my previous guest post

I have been in contact with Lundbeck to ask them a series of questions, in the beginning they were more that happy to accommodate, every email was replied to promptly. That was until the chat I had with Bob where we decided it was a good idea to copy Bob in on all the correspondence between myself and Lundbeck. It appears Lundbeck did not like this.

The first email I sent, with Bob cc'd, went unanswered. I waited a good few weeks but still nothing, I gave them the benefit of doubt and emailed again just in case they hadn't received it but yet again, no reply. Bob also told me that he had noticed an IP address he did not recognize had visited his blog, he decided to trace the IP and yep, you've guessed, it was Lundbeck in Copenhagen. By now I was getting majorly pissed. I decided to call Lundbeck and ask why they hadn't answered. This is the conversation that followed.

Conversation with Lundbeck employee 1.30pm 22/07/14

(CB - me, LU - Lundbeck)

CB - Hi can I speak to Ms Warrilow please?

LU - I'm sorry but she is not in today, it is anything I could help you with?

CB - Maybe you could but I'll have to explain the situation I'm in first.

LU - OK, go ahead.

CB - Back in 2004 I had a baby who developed severe abnormalities, she was incompatible with life and passed away at 23 weeks gestation. I was prescribed Citalopram at a dose of 60mg prior to, and during pregnancy. My GP knew I was trying to conceive and prescribed folic acid to me.

I was also told by more than one GP at my surgery that SSRI antidepressants were safe. I have a fair feeling citalopram caused my daughters birth defects. I had been in correspondence with Ms Warrilow who was answering some questions I had. We were in contact for several weeks but I have not had a reply to the last email I sent with a question, this was in December, or any subsequent emails asking why I was not being replied to.

LU - Oh, that's strange, maybe the question you had didn't have an answer. Why do you seem to think citalopram caused the birth defects, that's not a question there is an answer to, that's like asking if the sky is blue.

CB - I want to know because I am her mother and at the time no cause was found for her problems, she had normal chromosomes. I know from researching that SSRI's can cause birth defects.

LU - We recommend that the patient speaks to their GP, that is our guidance.

CB - I am way beyond "Speaking to my GP", I have had a meeting with the Clinical Director of the maternity hospital my daughter was born in, its in my records that he sent a yellow card warning to the Centre for Adverse Reactions in Scotland about the adverse reaction to Citalopram.

LU - When was this again, 2004, Oh I don't know if you will get any information, it was a long time ago.

CB - I have contacted the MHRA as my consultant contacted them. I wanted to ask if they had any information.

LU - The MHRA won't have any information, all reports are anonymous. I don't understand why you want to know, there is nothing that can give you a definitive yes or no.

CB - Would I be better contacting Lundbeck in Denmark directly? Or is there someone else I could speak to?

LU - Why would you want to do that, Eve already told you, we recommend you go back and see your GP.

CB - So all of this is my GP's fault for prescribing it?

LU - We tell the GP's to read the PIL, and the information we give them, and make their recommendations from that.

CB - But did the PIL or your information for GP's state the risk of birth defects in babies back in 2004?

LU - Oh we never recommend prescribing antidepressants in pregnancy, no studies have been done.

CB - There are other SSRI's, paroxetine being one, which is known to cause birth defects, I know citalopram is a category C, paroxetine is D.

LU - Oh, but we still do not recommend it in pregnancy.

CB - When will Ms Warrilow be back?

LU - Tomorrow, what is your name and I will get her to contact you?

CB - Cheryl Buchanan, I have emailed a couple of times and had no reply.

LU - It must be the spam filter, we have been very busy and maybe just haven't gotten to your emails.

CB - It is possible its because I have copied Mr. Bob Fiddaman in on the correspondence? He has been giving me help and advice and has a lot of knowledge about SSRI's. He also has a blog and told me his blog has been visited a number of times by an IP he did not recognize, after checking it he found it belongs to Lundbeck in Denmark so I think that you have been receiving my emails.

LU - I don't know anything about it. I will have Ms Warrilow contact you. Are you still taking Citalopram?

CB - No.

LU - Are you on a different SSRI?

CB - Yes but I am withdrawing from using it as I will not be a hypocrite and take something which more than likely killed my daughter.

LU - Are you doing this under GP's guidance.

CB - Yes. Thanks you for your time. Goodbye.

LU - No problem, bye.

I was dumbfounded. I awaited a response but once again was ignored. So I waited some more, just long enough for them to think I had gone away.

Then I called their head office again, this time the person who answered the phone was the one who I'd been speaking with by email.

Conversation with Ms W (Lundbeck) 17/02/14 - 4.30pm

CB - Hi can I speak to Ms Warrilow please?

LU - This is her speaking...

C - Hi, I am not sure if you know who I am but my name is Cheryl Buchanan, I was speaking to you through email a couple of months ago, about my daughters birth defects?

LU - Yes, I do remember

CB - I sent you an email back in December and I never got a response, I have since then emailed you several times and never got a reply.

LU - Oh, er, I think that was because there wasn't really anything else we could say to you.

CB - I understand that but it would have been more courteous if you could have replied telling me that, this situation is consuming my life at the moment and having to send repeated emails, with no answer, it doesn't help.

LU - Oh, yes, I do apologize.

CB - I actually called a couple of weeks ago and spoke to a colleague of yours, she took my details and assured me she would have you contact me.

LU - Oh, erm...

CB - I hope you understand I'm not blaming you personally, I know its absolutely nothing to do with you but a reply would have been helpful, even if to say you didn't have anything else to tell me.

LU - (Silence)

LU - The MHRA have been in touch with us, you asked in your email if they contacted us in 04, they didn't but have since, they might be able to help you. Would you like a copy of the information they sent us? It is anonymous but we figured it was you.

CB - I filled in another yellow card a couple of months ago and asked for them to contact me, I never got a reply, I imagine they have contacted you about the Yellow card I sent recently. If you could send me a copy of what they sent you I would really appreciate it.

LU - OK, that's not a problem.

CB - Can I ask a question? Do you know what the PIL stated about prescribing citalopram in pregnancy back in 2004, or could you find out? What I'm trying to figure out is if GP's would have known citalopram was a teratogen back then?

LU - I can get a copy of it, I'm sure it said use with caution but I can find out for you and send a copy of the 04 PIL to you.

CB - Do you know when the risks of prescribing in pregnancy were was added to the PIL, was it 2004?

LU - I'm not sure, the PIL changes all the time.

CB - I'm trying to figure out if GP's would have known Citalopram was a teratogen.

LU - I can get you a copy of the GP information and send it to you? I'm sure it would have said use with caution in pregnancy.

CB - That would be great

LU - Do we have your address, I don't think we do?

CB - No you wouldn't have, all our conversations were by email. (I give her my address)

LU - I will get that sent to you tomorrow, do you remember us sending you a permission form for you to sign so we can contact your GP?

CB - Yes but I don't have a printer so can't return it, could you send me a paper copy please?

LU - Of course, Ill get it send out to you along with the other information.

CB - Thank you for your time, bye.

LU - Bye.

While I had been awaiting a reply I decided to complain to the MHRA about Lundbeck's lack of response, just today they sent me a reply which seems to have been written by a robot and in no way at all answers the complaint I put to them.

Dear Ms Buchanan,

Thank you for your email regarding the lack of response from Lundbeck and your concerns regarding the product Citalopram. We are very sorry to hear about what has happened to you and your daughter.

Your email was treated as a patient report and we were as a consequence able to link this up with your previous correspondence with the Vigilance and Risk Management of Medicines Division.

In relation to Lundbeck your information has been passed to the Inspection, Enforcement and Standards Division who have responsibility for conducting Pharmacovigilance inspections of Marketing Authorization Holders (MAHs) such as Lundbeck. This information will be entered into the risk information system; this system is used to determine how often organizations are inspected. At such inspections we check how the MAH handles reports such as your own as they have responsibility for the on-going safety of products on the market. During any such inspection we do of course preserve the identity of any individuals such as yourself.

Once again, thank you for alerting us to this potential adverse reaction and the actions of the company.

Right now I am furious. This morning on my daily hunt of the net for info I was on Lundbeck's LinkedIn page. In the careers section their is a large photo header with the statement "Everyone deserves quality of life". How completley and utterly hypocritical. What about my daughters "quality of life"?

Because of a medication, made by them, which they knew in studies killed of the fetuses of pregnant rats and they marketed as being safe in pregnancy, my daughter is dead. She never got a chance of life. So Lundbeck, if you are reading this, please know that I'm not going to go away. I will keep doing my utmost to prove your are responsible for my child's and hundreds, possibly thousands, of other children's birth defects.

I have had several women come to me in the past few of weeks to tell me their story and how their children were born with birth defects after taking SSRI medication. I am not only doing this for my child, but for all the children whose lives have been damaged by your drugs.